Development and validation of a liquid chromatographic method for the analysis of squaric acid dibutyl ester and its impurities

Characterization of squaric acid dibutyl ester and its forced degradation products was achieved by coupling mass spectrometry (MS) to the liquid chromatographic (LC) system. The method was successfully applied for quality control purposes including assay and determination of related compounds as required by regulatory guidelines to ensure its safety and efficacy since no monograph is available in official compendia.